The Federal Trade Commission and the New York state attorney general Monday filed a complaint against a supplement company that claims its pills can help with age-associated memory loss.
The supplement, Prevagen, is heavily advertised, with commercials — including on national broadcast and cable networks such as CNN, Fox News, and NBC — claiming it can improve memory in 90 days. Ads feature charts depicting dramatic cognitive improvement among users. The FTC says these claims are deceptive.
“The marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection, in a statement. “But one critical thing these marketers forgot is that their claims need to be backed up by real scientific evidence.”
The company that markets Prevagen, Quincy Bioscience, denied the allegations in a statement Monday.
“We vehemently disagree with these allegations made by only two FTC commissioners,” the statement said. “This case is another example of government overreach and regulators extinguishing innovation by imposing arbitrary new rules on small businesses like ours.”
The $30 to $40 billion supplement industry has faced increasing scrutiny in recent years, with a flurry of criminal charges announced
in November 2015 and a push by the New York state attorney general to make sure supplements actually contain the ingredients listed on their labels.
One study found
that 23,000 emergency room visits each year in the US are related to dietary supplements.
In this case, the main study the FTC took issue with was a 2016 paper
called the Madison Memory Study, sponsored by Quincy Bioscience. That study has been wrongly touted as supporting the drug
’s benefits, according to the FTC.
The study found statistically significant benefits, but according to the complaint, that was not seen in the first analysis of the study data as a whole. The researchers proceeded to parcel the data into multiple subgroup analyses and eventually found only a few that “do not provide reliable evidence of a treatment effect,” the complaint says. The company said that it isn’t the FTC’s role to argue over data analysis.
“The sole dispute rests on the interpretation and analysis of the data, with the regulators attempting to hold the company to a standard that is unreasonable, scientifically debatable, and legally invalid,” the company’s statement said. “Their experts simply disagree with ours over how to interpret the study results. The FTC should not be the arbiter in matters of scientific debate.”
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Prevagen costs from $24 to $68 for a monthly supply and is sold at retailers such as Amazon, CVS, the Vitamin Shoppe, and Walgreens. From 2007 through mid-2015, sales of the supplement have topped $165 million, according to the complaint.
The lawsuit seeks refunds for consumers who bought Prevagen.
This is not the first time that Quincy Bioscience has found itself in hot water over the marketing of Prevagen. In 2012, it received an FDA warning letter, and in 2015, it was the subject of a class action lawsuit.
By Ike Swetlitz - STAT/Jan. 9, 2017